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The Courts

The Solicitor General's position in the case POM Wonderful LLC v. The Coca-Cola Company received some pushback from Supreme Court justices during oral arguments last week, with justices asking why the two statutes involved, the Food, Drug and Cosmetic Act (FDCA) and Lanham Act, could not be complementary.

The Solicitor General recently told the Supreme Court, in a case slated to be heard next week, that companies cannot bring false advertising cases when FDA explicitly regulates a product, although FDA laws do not broadly prevent them from doing so.

In a move that one lobbyist says should not be a surprise, the American Hospital Association is challenging HHS over the controversial two-midnights inpatient admission policy, arguing in two related lawsuits filed Monday (April 14) that the rule burdens hospitals with unlawful, arbitrary standards and deprives hospitals of proper Medicare payment for caring for patients.

States worry that if the Supreme Court sides with Coca-Cola in the POM Wonderful LLC v. The Coca-Cola Company, the ruling could spill over to interactions between state consumer protection laws and the Food, Drug and Cosmetic Act (FDCA), according to an amicus brief filed by 10 state attorneys general.

Several Supreme Court justices raised concerns Tuesday (March 25) that a range of crucial medical services -- such as vaccines and blood transfusions -- might also be denied to employees based on their employers' religious views if the court rules that for-profit corporations do not have to comply with the ACA’s controversial contraception coverage requirement based on religious objection.

The Supreme Court's unanimous decision last week reiterate its earlier stance that patent owners bear the burden of proof in a declaratory judgment of non-infringement in patent litigation restores clarity that had been muddied by a diverging lower court ruling, an industry attorney said.

The American Hospital Association, several state hospital associations and four hospital systems on Wednesday (Jan. 22) took the first steps toward challenging CMS’ two-midnights inpatient admissions policy, according to AHA News.

A bicameral group of lawmakers -- including top Republicans on key committees and one of the architects of the generic drug law -- say FDA's proposal that generic drug makers unilaterally update their labels with new safety information conflicts with statutory requirements that Congress has declined to change in recent decades.

The top priority for the generic drug industry in 2014 will be combating a new regulation aimed at requiring generic drugmakers to make labeling changes to reflect new safety information -- a shift from the current FDA regulatory paradigm that would be "draconian," according to the generic drug lobby's top official, who pledged broad outreach on the matter extending to the White House.

Triclosan in toothpaste could be just as harmful if not more so than in hand washes, the Natural Resources Defense Council argues in filing a recent lawsuit that comes on the heels of FDA action on antibacterial hand washes.

A recent government filing countering application of the First Amendment in a false claims case involving off-label promotion shows that the government is trying to limit a high-profile off-label ruling to cases brought under the Food, Drug and Cosmetic Act, industry attorneys said.

As the Supreme Court agreed Tuesday (Nov. 26) to take on the highly controversial issue of the ACA's contraceptive coverage requirements, the Obama administration joined by women's groups and some health care providers urged the high court to resist letting employers dictate whether their female employees should be able to access such coverage.

Home health providers are planning a “March on the Capitol” to protest CMS' cuts to home health pay in the 2014 final pay rule and say that, if necessary, they will work with seniors' advocates to take the agency to court.

A federal district court last week made it clear that a company developing a biosimilar can't shoot down an innovator's patent without first filing a formal biosimilar application with FDA and engaging in the subsequent “patent dance” spelled out in the health reform law's biosimilar provision.

Recent oral arguments in a high-profile medical device patent case signal the Supreme Court may reverse a federal circuit decision that shifted the burden of proof in declaratory judgments of non-infringement to the licensee of a patent, several attorneys following the case said.

The Treasury Department on Friday (Sept. 13) told Sen. Orrin Hatch (R-UT) that the ACA's premium tax credits are not available to workers enrolled in multi-employer plans because the workers are already covered by employer-sponsored insurance that receives a tax exclusion, a final decision handed down following a controversial, months-long effort by unions for multi-employer plan enrollees to be eligible for those subsidies.

The Senate Finance and House Ways & Means committees are expected to release around the end of the month similar draft bills to replace the Sustainable Growth Rate formula that do not include offsets for the cost of the bills, provider lobbyists say. But lobbyists don't expect Congress to agree on an SGR bill by the latter half of October when the country is expected to hit its debt limit so they hope that a large legislative vehicle will emerge in December to which Medicare physician payment reform could be attached.

As lawmakers seek ways to pay for fixing the Medicare physician-pay formula, CMS actuaries estimate that a two-year-old legislative proposal by Sen. Tom Coburn (R-OK) and former Sen. Joe Lieberman (D-CT) would reduce Medicare spending by $536 billion over a decade. The legislative proposal includes a new benefit structure with a uniform deductible and a cap on out-of-pocket spending, a higher eligibility age, limits on Medigap coverage, higher premiums, home health pay cuts and reductions to hospital bad debt payments.